A New Form of Paxil Controls Hot Flashes Without Hormones

It’s not hard to understand that finding a treatment for something with an unknown cause might be difficult. However, medicine does find such treatments – usually by trial and error. Quite often that means a drug typically used for treating one kind of disease turns out to be effective on something else. That’s the case for Brisdelle, a product of Noven Pharmaceuticals (U.S.), which is a low dosage version of paroxentine – better known as Paxil. Paxil is a long-standing antidepressant drug used for a variety of psychological disorders. As Brisdelle, Paxil becomes a treatment for hot flashes.

The thing about hot flashes is that while millions of women have them during menopause (and sometimes before and after as well), the exact cause is unknown. There is some evidence of a relationship to hormone production (at menopause, which makes sense) and a relationship to vascular (blood vessel) constriction, but neither the direct physiological causes nor the underlying biochemical causes are known. Nevertheless, researchers have been working on treatments for hot flashes for decades.

For the most part, hot flashes are periods when the body seems to ‘heat up’ – body temperature rises, the face and other parts of the body feel hot and flushed, and these symptoms are often accompanied by sweating and accelerated heartbeat. While “hot flashes” are not a life-threatening problem (at least not directly), for a certain percentage of women going through menopause they are definitely lifestyle altering and can, in fact, lead to serious psychological and even physical problems.

The main issue with hot flashes is not the general symptoms, which vary a great deal, but in their intensity, frequency and duration. A certain percentage of women, roughly 20-30%, have some combination of intense (multiple symptoms at a high level), frequent (up to several times a day) and long-lasting episodes (up to thirty minutes). For these women, hot flashes are not only inconvenient and disconcerting; they can be socially devastating and psychologically destructive.

These more or less extreme hot flash conditions – affecting several million women in the United States alone – stimulated the medical research for a treatment. The first of these treatments, and still among the most common, are hormone-based approaches. Following the lead that most of the problems with menopause are caused by hormone production (mainly the decline in estrogen), researchers worked with a variety of hormone replacement therapy strategies. This approach is general, and when it works, the reduction or suppression of hot flashes is just one of the symptoms of menopause affected.

However, hormones have powerful and sometimes unpredictable effects on women. Over the decades, since hormone treatments were introduced women, doctors and researchers learned that there were risks. By the year 2000, it became obvious that while hormone treatments were effective for some women, it was not a good idea to use them too often and for every case. Research needed to find ways of treating menopause symptoms, hot flashes specifically, by non-hormone means.

This search turned out to be difficult. It’s taken more than a decade of research to discover the potential of some antidepressant drugs – known as selective serotonin reuptake inhibitors (SSRIs) – to treat hot flashes. These drugs, of which paroxentine/paxil is one, apparently affect hormone regulation in the amygdala (so current thinking goes), which as one of the effects, alleviates the hormone imbalances that may cause/contribute-to hot flashes.

Unfortunately, in its usual clinical dosage for depression and other psychological treatments, paxil is also a powerful drug with many potentially harmful side effects. In fact, intuition alone would suggest that taking a serious dose of an antidepressant for menopause symptoms might light lead to unwanted results. That’s where the research on Brisdelle began – the search for a biochemical combination and dosage involving paxil but at a level reducing side effects to a minimum.

Dosage is crucial and eventually, through several clinical trials, researchers determined the most effective dosage levels. Brisdelle contains only 7.5 milligrams of paxil, compared to the minimum use dosage of paxil at 10 milligrams. While clinical trials did not establish an unimpeachable record for treating hot flashes – the expert panel reviewing the Brisdelle trials ruled its effect to be marginal – finally, Brisdelle became the first U.S Food and Drug Administration approved non-hormone treatment for hot flashes, and is scheduled for commercial distribution in November of 2013.